1 Medical Apology Laws, Mandatory Reporting, and Adverse Event Reporting Under the PSQIA By

25 Pages·2009·0.11 MB·English

Medical Apology Laws, Mandatory Reporting,
and Adverse Event Reporting Under the PSQIA

By: Michael A. Morse, Esquire

I. Medical Apology Laws:

A. Introduction
Curbing medical malpractice lawsuits remains at the forefront of the national
debate over healthcare reform. Although the number of malpractice lawsuits has
remained relatively steady over the past few years, the total monetary cost, in terms of
payments and insurance premiums, has risen steadily. Recently, a growing number of
states have taken the lead in trying to curb medical malpractice cases by encouraging
dialogue between physicians and patients about medical errors. One of the most popular
and successful efforts by states to reduce medical malpractice costs has been the passage
of so-called “medical apology laws.” These laws generally provide that a medical
provider’s expression of an “apology” to a patient following a medical error can not be
used as evidence against the provider in a subsequent malpractice lawsuit.
Thirty-five states and the District of Columbia currently have either statutes or
rules of evidence that prevent the use of apologies as evidence of fault in medical
malpractice cases. Twenty-five of these laws were enacted in 2005 or later; only a
handful existed before the year 2000. The express purpose of these statutes is “to reduce
the incidence of claims and lawsuits arising out of . . . unanticipated outcomes [of
medical care].”
B. Variances in State Apology Laws

As of September 2008, thirty-five states and the District of Columbia have
adopted rules of evidence or other statutory restrictions on the use of apologies in medical
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malpractice cases. These statutes differ in ways that are often subtle, but which have
dramatic implications for practical applications, including: (1) the type of communication
protected; (2) by whom the protected communication may be made; (3) to whom the
protected communication may be made; (4) the sentiments protected; and (5) the context
in which a communication will be protected. Additionally, a number of states have
unique provisions with no analogue in their counterparts around the country, including:
time limits on protected apologies; protection for apologies to domestic partners;
protection for payment of medical expenses; and prohibition on settlements during
patient convalescence.
1. Types of Communication Protected

The vast majority of state apology laws protect written statements, oral
statements, and conduct (usually formulated as “statements, affirmations, gestures, and
conduct”). Two states, North Carolina and South Dakota, protect only a limited class of
conduct: that which assists an individual affected by an adverse outcome. One state,
Vermont, does not protect written apologies or conduct. Utah does not protect unsworn
statements.
2. Who Makes the Communication

Many apology laws impose requirements on who may make an apology within
the protections of the law. Twenty-one jurisdictions limit their protections to apologies
made by healthcare providers. All but two of these jurisdictions expressly permit the
employees and/or agents of a healthcare provider to apologize on the provider’s behalf.
The other fifteen states impose no such restriction; in those states, apologies are
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inadmissible if they fall within the remaining provisions of the statute, regardless of who
apologizes.
3. Who Receives the Communication

Nearly every apology law contains a provision defining the class of persons to
whom an individual may apologize within the protection of the statute; only seven protect
apologies without regard to the recipient’s identity. The other twenty-nine apology laws
contain provisions that, for the most part, limit the class of individuals to whom one may
apologize to the victim of an accident or adverse medical event, the victim’s family, the
victim’s representative, or some combination thereof.
The restrictions on permissible recipients of protected apologies represent the
greatest source of practical variance between these statutes. Two statutes protect
apologies to the friends of patients. Two protect apologies made to domestic partners of
a patient. Virginia’s statute does not protect apologies to the patient, as it applies only in
wrongful death actions.
While the most common formulation protects apologies to the patient, the
patient’s family, or the patient’s agent or representative, the definition of “family” varies
in ways that create practical pitfalls for healthcare practitioners. For example, many
apology laws offer no protection to apologies made to adopted relatives. Some of those
that include adopted relatives in the definition of family include only adopted siblings,
excluding by omission adopted parents, adopted children, and any other adopted
relationship. Oklahoma’s statute omits stepmothers from the definition of “family” while
including stepfathers.
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Because of this broad variance in apology laws, healthcare providers who wish to
avail themselves of the protection of these laws must take special care when determining
to whom an apology should be made.
4. Sentiments Protected

While there are a wide range of formulations of which sentiments are protected by
apology laws, only a few of these contain meaningful differences. What distinctions one
might draw between statements expressing “sympathy” and those expressing
“compassion, commiseration, and condolence” are unlikely to be worthy of practical
consideration. The more critical distinctions are those between expressions of sympathy
and admissions of fault. Five apology laws protect expressions of mistake, error, and
fault. Nineteen of the remaining thirty-one explicitly define as admissible statements
acknowledging fault or liability. Three apology laws protect explanations of the
circumstances which led to an adverse medical event. Recognizing the extent of the
protections afforded by these laws is essential to crafting an apology that fully
acknowledges an adverse event but does not exacerbate the healthcare provider’s legal
exposure.
5. Context of Apology

Most apology laws impose a restriction on the context in which an apology
qualifies for protection. Eleven statutes require only that the apology relate to the pain,
suffering, injury, or death of an individual as a result of an unanticipated outcome of
medical care. Six require that the apology relate to the pain, suffering, injury or death of
an individual as a result of an accident, whether medical or otherwise. Several have
unique context provisions, such as a requirement that the healthcare provider apologize
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within a certain time after discovery of a medical error. This variance in protected
contexts makes it important for healthcare providers to determine whether the context is
protected under the relevant apology law before issuing an apology.
C. State Apology Laws :

At the present time, there are roughly 36 states that have enacted some form of
apology laws or regulations, including:
STATE STATUTORY CITATION
Arizona ARIZ. REV. STAT. ANN. §12-2605 (2005)
California CAL. EVID. CODE § 1160 (West 2000)
Colorado COLO. REV. STAT. ANN. §13-25-135 (West 2003)
Connecticut CONN. GEN. STAT. ANN. §52-184d (West 2005)
Delaware DEL. CODE ANN. tit. 10, § 4318(b) (2008).

District of Columbia D.C. CODE § 16-2841 (2008).
Florida FLA. STAT. ANN. §90.4026 (West 2001)
Georgia GAA CODE ANN. §24-3-37.1 (West 2005)
Hawaii HAW. REV. STAT. § 409.5 (2008).
Idaho IDAHO CODE ANN. § 9-207(1) (2008).
Illinois 110 ILL. COMP. STAT. ANN. 5/8-1901 (West 2005)
Indiana IND. CODE ANN. §§ 34-43.5-1-3, 34-43.5-1-4 (2008).
Iowa IOWA CODE § 622.31 (2008).
Louisiana LA. REV. STAT. ANN. § 13: 3715.5 (2005)
Maine ME REV. STAT. ANN. TIT. 24, § 2907 (2005)
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Maryland MD. CODE ANN., CTS. & JUD. PROC. §10-920 (West
2004)
Massachusetts MASS. GEN. LAWS ch. 233, §23D (West 1986)
Missouri MO. ANN. STAT. § 538.229 (West 2005)
Montana MONT. CODE ANN. §26-1-814 (2005)
Nebraska NEB. REV. STAT. § 27-1201(1) (2008).
New Hampshire N.H. REV. STAT. ANN. § 507-E:4 (2006)
North Carolina N.C. Gen. Stat. § 8C-1, Rule 413 (2004).
North Dakota N.D. CENT. CODE § 31-04-12 (2008).
Ohio OHIO REV. CODE ANN. §2317.43 (West 2004)
Oklahoma OKLA. STAT. tit. 63, § 1-1708.1H (2005)
Oregon OR. REV. STAT. ANN. §677.082 (West 2003)
South Carolina S.C. CODE ANN. § 19-1-190(D) (2007).
South Dakota .D. CODIFIED LAWS § 19-12-14 (2008).
Tennessee TENN. R. EVID. 409.1 (2008).
Texas TEX. CIV. PRAC. & REM. CODE ANN. §18.061 (Vernon
1999)
Utah UTAH CODE ANN. § 78B-3-422 (2008).
Vermont VT. STAT. ANN. tit. 12, § 1912(a) (2007).
Virginia VA. CODE ANN. §8.01-52.1 (West 2005)
Washington WASH. REV. CODE ANN. § 5.66.010 (West 2002)
West Virginia W. VA. CODE ANN. § 55-7-11a (West 2005)
Wyoming WYO. STAT. ANN. § 1-1-130 (2004)
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II. Mandatory Reporting of Medical Errors and Adverse Events
A. Federal Regimes for Mandatory Adverse Event Reporting
There currently exist a number of federal regimes for mandatory reporting of
adverse events. These federal regimes, which have evolved slowly over the past decade,
are highly specialized and much more narrowly focused than state mandatory reporting
statutes. Unlike state reporting statutes, the various federal regimes generally apply to a
limited set of adverse events, and have relatively specific guidelines for reporting these
events. The focused nature of these federal reporting regimes, however, can result in
failures of compliance by healthcare providers and compliance officers. This leaves
healthcare providers and entities exposed to potential sanctions for failing to timely report
adverse events, as well as opening the door to a number of collateral consequences,
including whistleblower suits where the accurate reporting of adverse events is a
condition of payment of public funds.
1. Medical Device Reporting
Congressional regulations require that medical device “manufacturers”i and
“device user facilities”ii report deaths or serious injuriesiii that result from the use of
medical devices.iv Device user facilities are required to report these adverse events
within ten business days to the Food and Drug Administration (FDA) Center for Devices
and Radiological Health and, if the manufacturer’s identity is known, to the manufacturer
as well. The manufacturer must, in turn, investigate the event and provide additional
information to the FDA within thirty calendar days.v Because of the broad definition of
manufacturer in this context, it is important for any device user, including hospitals and
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other medical facilities, to carefully determine whether it might also be deemed a device
manufacturer for reporting purposes.
2. Vaccine Adverse Event Reporting System
The Vaccine Adverse Event Reporting System (VAERS) accepts reports from
health care providers, manufacturers, and the public regarding adverse events associated
with U.S. licensed vaccines. VAERS is administered jointly by the FDA and the Centers
for Disease Control (CDC); both entities receive reports via the VAERS. Manufacturers
and health care providers are required to report any adverse events through VAERS, with
sanctions for failure to report generally limited to license revocation or similar
disciplinary action.vi
3. Current Good Tissue Practice regulations
Human cells or tissue, other than blood, intended to in any way be transferred into
a human being is regulated by the FDA as a human cell, tissue, and cellular and tissue-
based product, or “HCT/P.” HCT/P “establishments” (which recover, process, store,
label, package, manufacture, or distribute HCT/P), are required to investigate adverse
reactions involving any communicable disease associated with HCT/P it distributed and
to report any such reactions that are fatal, life-threatening, result in permanent
impairment or harm, or require medical or surgical intervention.vii Health care providers
that do not qualify as HCT/P establishments are encouraged to voluntarily report adverse
reactions to the FDA and to the HCT/P establishment from which the HCT/P was
acquired.viii

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4. Blood and Blood Product Manufacturing Errors:
Blood and blood product manufacturersix are required to report any event related
to the manufacture (including testing, processing, packing, labeling, or storage) or the
holding or distribution of blood or blood products which represents a deviation from
good manufacturing practice or standards, or represents an unexpected event that may
affect the safety, purity, or potency of the product.x These reports must be made to the
Center for Biologics Evaluation and Research (CBER), Office of Compliance and
Biologics Quality (OCBQ) no more than forty-five calendar days from the date of
discovery of information reasonably suggesting a reportable event has occurred.
5. Deaths Related to Patient Restraint or Seclusion:
The Centers for Medicare and Medicaid Services (“CMS”) requires hospitals, as
part of the Medicare Conditions of Participation, to report to their CMS any patient death
that occurs while the patient is restrained or in seclusion, within 24 hours after the patient
has been removed from restraint or seclusion, and within one week after restraint or
seclusion where it is reasonable to assume that the patient’s death resulted in part from
restraint or seclusion.xi “Reasonable to assume” includes, but is not limited to, deaths
related to restrictions of movement for prolonged periods of time, or death related to
chest compression, restriction of breathing or asphyxiation. This reporting to the CMS is
to be done via telephone by the close of business on the business day on which the
hospital learned of the patient’s death.

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B. State Legislation Requiring Mandatory Reporting of Medical Errors
Most mandatory reporting obligations come from various state laws and
regulations, as opposed to the narrowly tailored federal reporting regimes. Although a
small number of states have had reporting requirements for some time, most have just
recently adopted reporting requirements. As of July 2006, at least 33 states had some
form of mandatory or voluntary requirement for reporting medical errors. At least 24
states had some type of mandatory reporting requirement. A number of states are
currently considering the adoption of mandatory reporting rules. Moreover, given the
increasing public attention paid to medical errors, the number of states with reporting
requirements is likely to continue to grow.
There is little uniformity amongst these state reporting requirements, and they are
subject to statutory and regulatory changes, as well as updates to interpretive guidelines,
web-sites and forms. In a number of key aspects the state reporting requirements differ
quite dramatically, including: (1) the definition of an “adverse event;” (2) what type of
information needs to be reported; (3) when the reporting must be made; (4) the
consequences, if any, for failing to report; and (5) what the state does with the adverse
event information it receives from healthcare facilities.
Although the differences in the state mandatory reporting statutes far outweigh
the similarities, one common element is that nearly all provide some degree of
confidentiality over adverse event reports. In general, these confidentiality provisions
prevent adverse events reports from being used in subsequent civil lawsuits. A few states
go even further by prohibiting the use of adverse event reports in criminal and
administrative proceedings. The scope and strength of these confidentiality measures
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